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Low Flux Hemodialyzer

by Jafron Blood Purification Technologies Co., Ltd China EUDAMED

Ref JM-15LModel JM-10L\JM-11L\JM-12L\JM-13L\JM-14L\JM-15L\JM-16L\JM-17L\JM-18L\JM-19L\JM-20L

EMDN F01060101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697355616LFHTU Basic UDI-DIDate10 Dec 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
JM-10L\JM-11L\JM-12L\JM-13L\JM-14L\JM-15L\JM-16L\JM-17L\JM-18L\JM-19L\JM-20L, JM-15L
Primary DI / UDI-DI
06973556160457
Basic UDI-DI
697355616LFHTU
EMDN Code
F01060101 DIALYSERS - UFC < 18 ml/h/mmHg, CELLULOSE MEMBRANES
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000006021
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jafron Blood Purification Technologies Co., Ltd

See all devices from Jafron Blood Purification Technologies Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED bb660802-a365-446d-8bec-03a32efb6597 61 fields · synced 23 Oct 2026